A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

Purpose

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

Condition

  • Alzheimer Disease

Eligibility

Eligible Ages
Between 55 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1). - Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup. - Patient must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma. - Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).

Exclusion Criteria

  • Patients will not be able to participate if they have: i) Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features. ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KarXT
  • Drug: KarXT
    Specified dose on specified days
    Other names:
    • BMS-986510
Experimental
Placebo
  • Drug: Placebo
    Specified dose on specified days

Recruiting Locations

Chandler Clinical Trials, LLC
Chandler, Arizona 85224
Contact:
Muhammad (Osman) Salim Khan, Site 1227
480-716-4590

Gilbert Neurology Partners - PLLC - Avacare
Gilbert, Arizona 85297
Contact:
Jonathan Hodgson, Site 1247
602-761-9631

Banner Alzheimer's Institute
Phoenix, Arizona 85006-2528
Contact:
Ganesh Gopalakrishna, Site 1217
602-839-6900

Scottsdale Clinical Trials
Scottsdale, Arizona 85260-6742
Contact:
Khalid Salim, Site 1220
480-382-7909

Advanced Research Center, Inc.
Anaheim, California 92805-5854
Contact:
Steven Macina, Site 1104
714-999-6688

Inland Psychiatric Medical Group (IPMG)-Chino
Chino, California 91710
Contact:
Nandita Puchakayala, Site 1244
909-488-9116

Long Beach Research Institute, LLC
Long Beach, California 90805
Contact:
Ashley Duzik, Site 1230
562-471-3773

USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)
Los Angeles, California 90033-5313
Contact:
Lon Schneider, Site 1226
323-442-3715

NRC Research Institute - Orange - PPDS
Orange, California 92868-2847
Contact:
Daniel Chueh, Site 1228
714-289-1100

SC3 Research - Pasadena - 960 E. Green St
Pasadena, California 91106
Contact:
M. Lorraine Purino, Site 1043
626-250-2070

Prospective Research Innovations 8577 Haven Ave
Rancho Cucamonga, California 91730
Contact:
Tarek Ezzeddine, Site 1213

University of Connecticut Health Center
Farmington, Connecticut 06030
Contact:
Neha Jain, Site 1222
860-790-7354

Genesis Trust Research Group
Atlantis, Florida 33462
Contact:
Rodolfo Trejo, Site 1225
561-509-9956

Envision Trials LLC
Bonita Springs, Florida 34134
Contact:
Daniel Mandri, Site 1020
305-819-2909

JY Research Institute Inc
Cutler Bay, Florida 33189-1230
Contact:
Suez Oramas Mingo, Site 1138
305-424-8696

Arrow Clinical Trials
Daytona Beach, Florida 32117-5532
Contact:
David Billmeier, Site 1023
386-278-8000

Quantum Laboratories, Inc - West Palm Beach Office
Deerfield Beach, Florida 33442
Contact:
Jose De La Gandara, Site 1224
954-786-7331

Integrity Clinical Research LLC - 21st Street
Doral, Florida 33122-1620
Contact:
Lucinda Cuervo-Ramos, Site 1164
305-888-0410

New Life Medical Research Center -3750 W 16th Ave
Hialeah, Florida 33012-4648
Contact:
Jorge Betancourt, Site 1120
305-456-7782

Research in Miami, Inc
Hialeah, Florida 33013
Contact:
Dolores Sanchez Cazau, Site 1237
305-889-6670

Nexus Clinical Research Center- NRC
Homestead, Florida 33030
Contact:
John Cintron, Site 1229

K2 Medical Research - Lady Lake
Lady Lake, Florida 32159
Contact:
Craig Curtis, Site 1040
407-426-9299

Homestead Associates in Research Inc
Miami, Florida 33032
Contact:
Angel Carrasco, Site 1159
786-422-7374

Premier Clinical Research Institute
Miami, Florida 33122-1335
Contact:
Emelina Arocha, Site 1021
305-445-5994

Wellness Research Center Inc - Miami
Miami, Florida 33135-1601
Contact:
Brian Villa, Site 1125
786-238-7099

A & D Doctor Center
Miami, Florida 33135-2968
Contact:
Yordan Orive Gomez, Site 1236
305-223-2000

Floridian Neuroscience Institute-1901 SW 1 St
Miami, Florida 33135
Contact:
Emilio Mantero-Atienza, Site 1115
305-326-0776

Miami Jewish Health Systems
Miami, Florida 33137
Contact:
Marc Agronin, Site 1010
3057518626x2403

MedOne Clinical Research LLC
Miami, Florida 33145-2455
Contact:
Thierry Jacquemin, Site 1143
305-359-7666

My Community Research Center, Inc - 7480 Bird Rd
Miami, Florida 33155-6630
Contact:
Cesar Guerrero, Site 1113
786-359-4867

Future Care Solution LLC
Miami, Florida 33165-3947
Contact:
Pilar Trueba, Site 1129
305-888-0410

Reliant Medical Research
Miami, Florida 33165
Contact:
Carlos Ramirez Calderon, Site 1150
786-801-0912

Novel Clinical Research Center, LLC.
Miami, Florida 33173-1474
Contact:
Heber Varela, Site 1006
000-000-0000

Dade Research Center - Miami FL - 7600 SW 87th Ave
Miami, Florida 33173
Contact:
Maria Nualart, Site 1111
208-346-8900

Serenity Research Center
Miami, Florida 33176-1451
Contact:
Sergio Jaramillo, Site 1235
305-596-2080

IMIC LLC- 9380 SW 150th Str
Miami, Florida 33176-7947
Contact:
Leon Ramon, Site 1147
786-600-7005

New Gen Health
Miami, Florida 33176
Contact:
Roberto Hernando, Site 1234
305-892-1035

Floridian Research Institute- Ives Dairy Road
Miami, Florida 33179-2537
Contact:
Gretel Trullenque, Site 1105
786-391-1137

High Quality Research
Miami, Florida 33184-1412
Contact:
Jorge Gonzalez, Site 1157
305-392-0244

New Med Research
Miami Gardens, Florida 33056-4000
Contact:
Marta Fernandez, Site 1126
305-269-7100

Panax Clinical Research
Miami Lakes, Florida 33014
Contact:
Robert Perry, Site 1209
305-698-4500

Angels Clinical Research Institute - Miami Lakes - Palm Springs - PPDS
Miami Lakes, Florida 33016
Contact:
Yanely Pineiro Puebla, Site 1118
786-218-1733

Aqualane Clinical Research
Naples, Florida 34105
Contact:
William Justiz, Site 1246
941-436-6838

Sensible HealthCare, LLC
Ocoee, Florida 34761-2964
Contact:
Kelly Taylor, Site 1212
407-654-2724

Nova Psychiatry
Orlando, Florida 32803
Contact:
David Medina, Site 1242
407-823-8421

Combined Research Orlando Phase I-IV LLC
Orlando, Florida 32807-3555
Contact:
Eric Carbonell, Site 1112
407-440-4493

Neurology Associates of Ormond Beach
Ormond Beach, Florida 32174-3101
Contact:
David McDonald, Site 1204
386-673-2500

Progressive Medical Research (Duplicate)
Port Orange, Florida 32127
Contact:
Alexander White, Site 1205
386-304-7070

Cordova Research Institute- Sweetwater
Sweetwater, Florida 33182
Contact:
Delores Macksoud, Site 1133
786-631-3890

Angels Clinical Research Institute Tampa - Palm Springs - PPDS
Tampa, Florida 33614-2846
Contact:
Al Robaina, Site 1123
813-931-0128

Guardian Angel Research
Tampa, Florida 33614
Contact:
Sadaf Bazargan, Site 1124
813-300-3300

Interventional Psychiatry of Tampa Bay
Tampa, Florida 33629-5837
Contact:
Jamie Fernandez, Site 1110
813-251-1800

Premiere Research Institute at Palm Beach Neurology, PA
West Palm Beach, Florida 33407-3209
Contact:
Paul Winner, Site 1216
561-845-0500

Agile Clinical Research Trials, LLC
Atlanta, Georgia 30328-5532
Contact:
Vasundhara Cheekati, Site 1206
404-382-8660

McLean Hospital
Belmont, Massachusetts 02478-1064
Contact:
Arkadiy Stolyar, Site 1223
617-855-2136

Tufts Medical Center - 800 Washington St - PPDS
Boston, Massachusetts 02111-1552
Contact:
Brent Forester, Site 1245
617-636-3108

Boston Neuro Research Center
North Dartmouth, Massachusetts 02747-2612
Contact:
Mushtaque Chachar, Site 1243
508-925-7403

Elixia Health - Springfield - Elixia - PPDS
Springfield, Massachusetts 01103
Contact:
Susan Smiga, Site 1239
413-305-1142

Neurobehavioral Medicine Group (NBMG)
Bloomfield Township, Michigan 48302-1909
Contact:
Richard Jackson, Site 1248
412-916-2425

Precise Research Centers
Flowood, Mississippi 39232
Contact:
Joseph Kwentus, Site 1132
601-420-5810

Advanced Memory Research Institute - CenExel - PPDS
Toms River, New Jersey 08755
Contact:
Arun Singh, Site 1202
732-341-9500

Bio Behavioral Health
Toms River, New Jersey 08755
Contact:
Ashok Patel, Site 1232
732-244-2299

Five Towns Neurology, PC
Woodmere, New York 11598-1739
Contact:
David Steiner, Site 1025
516-239-1800

Triad Clinical Trials - 515 College Rd
Greensboro, North Carolina 27410-3311
Contact:
Richard Montgomery, Site 1221
336-235-0991

AMC Research, LLC - Flourish - PPDS
Matthews, North Carolina 28105-8336
Contact:
Mohammad Bolouri, Site 1214
704-364-4000

West Clinical Research
Morehead City, North Carolina 28557
Contact:
Patrick Morgante, Site 1215
252-515-0050

Ohio State University
Columbus, Ohio 43221
Contact:
Douglas Scharre, Site 1201
614-293-4560

Insight Clinical Trials LLC - Independence
Independence, Ohio 44131
Contact:
Mark Stillman, Site 1249
216-444-8897

The Rivus Wellness & Research Institute
Oklahoma City, Oklahoma 73112
Contact:
Marvin Peyton, Site 1016
405-317-5783

Alzheimer's Disease and Memory Disorders Center at Rhode Island Hospital
Providence, Rhode Island 02903
Contact:
Chuang-Kuo Wu, Site 1218
714-456-7002

Vanderbilt Psychiatric Hospital
Nashville, Tennessee 37212-3133
Contact:
Jo Wilson, Site 1211
615-322-4967

Epic Medical Research LLC - DeSoto - HyperCore - PPDS
DeSoto, Texas 75115-2043
Contact:
Haresh Boghara, Site 1121
972-777-6956

Advanced Neuro Research Center - El Paso
El Paso, Texas 79912-1743
Contact:
Aamr Herekar, Site 1208
505-903-1715

AIM Trials
Plano, Texas 75093-8225
Contact:
Sejal Mehta, Site 1238
972-267-1988

Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
San Antonio, Texas 78229-3901
Contact:
Antonio Teixeira, Site 1210
210-567-8229

Conquest Research - Arlington
Arlington, Virginia 22205
Contact:
Henry Tran, Site 1241
703-717-7755

Santa Cruz Behavioral PSC
Bayamón, Puerto Rico 00961-6910
Contact:
William Julio De Jesus, Site 1303
7877984592

CDT Grupo Medico San Pablo Inc.
Bayamón, Puerto Rico 961
Contact:
Ismael Toro-Grajales, Site 1301
8888888888

Instituto De Neurologia Dra. Ivonne Fraga,Psc
San Juan, Puerto Rico 00918-4502
Contact:
Ivonne De L Fraga Berrios, Site 1302
7874035534

Barbara Diaz Hernandez MD Research Inc
San Juan, Puerto Rico 00926-3160
Contact:
Ileana Fumero-Perez, Site 1304

More Details

Status
Recruiting
Sponsor
Karuna Therapeutics

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com